Container containing at least two solid materials, and use thereof

ABSTRACT

This invention relates to a container having at least one inlet and/or outlet and containing at least two different solids arranged in layers as well as the use of said container for preparing a dialysate. In particular, a flexible bag is described, having three layers of different solids, where the middle layer consists of a solid which is compatible with the two adjacent layers and thus forms a separating layer between the two other layers. The layers are secured in place during shipping by vacuum packing.

This is a nationalization of PCT/EP02/13334 filed Nov. 27, 2002 andpublished in German.

This invention relates to a container having at least one inlet and/oroutlet, said container containing at least two different solids arrangedin layers as well as the use of said container for producing a liquiddialysate.

For treatment of a patient suffering from renal insufficiency, dialysisis performed to treat patients suffering from renal insufficiency. Thisis performed either in the peritoneum or through extracorporeal dialysisor filtration of blood. These two methods have in common the fact thatdialysis fluids or dialysates take up the degradation products ofmetabolism. These dialysates usually contain high levels of sodiumchloride and other electrolytes such as calcium chloride or potassiumchloride, a buffer substance such as bicarbonate or acetate and acid toestablish a physiological pH plus optionally glucose as an osmoticagent.

Dialysates are either supplied as ready-to-use solutions or they areprepared on site from concentrates, including solid concentrates. Solidsoffer the advantage of a small package volume and a low weight. Althoughsolids also have disadvantages—electrolyte salts, for example, arehighly hygroscopic—there is a trend toward offering only solidcomponents for preparation of dialysates.

The solids are usually salts or crystals which may be in powder form orin granular form. European Patent EP 0 287 987 describes a granularmixture of the ionic components needed for preparation of a dialysate.German Patent DE 43 03 372 describes a bag for holding solid or liquidconcentrate, usually of bicarbonate, which is used for preparing thedialysate and is connected directly to a dialysis machine.

Only components that will not react during their storage or otherwiseinfluence one another through their chemical and/or physical properties,i.e., substances that are mutually compatible, are stored together inone container. Substances which under some circumstances can under somecircumstances influence one another's chemical and/or physicalproperties are called incompatible substances. The lack of compatibilityneed not occur spontaneously but may also occur during a process towhich the components are usually subjected, such as sterilization ofdialysates.

To overcome this problem, separate storage has been preferred, whetherin separate containers or containers having multiple compartments, sothat the substances are mixed only shortly before the treatment.However, this results in other problems such as the problem of creatinga connection system between the sterile containers or the individualcontainers of the dialysis machine, whether by joining key-and-lockconnection systems that fit together, by breaking open a connectingchannel or by tearing open a peelable seam. In addition, it is possiblethat the joining of the individual components may not be complete and/oronly one of the components may be administered.

The object of the present invention is therefore to provide a containerwhich avoids the disadvantages that have become known in the state ofthe art. This object is achieved through the features of the firstclaim.

Characteristic of this invention is the layered bed of at least twosolids within a container. The solids should preferably be componentsfor a dialysate and are in the form of a powder, crystals or granules,because the dialysate components are prepared from salts or glucose. Thesolids contained in it may be water-soluble but need not be. In the caseof solids that are to form components of a dialysate, they are of coursewater-soluble. In addition, use of such a container for preparing adialysate is thus also claimed.

If substances that are not compatible are used to fill the container,the layers must be arranged with a distance between them according tothis invention. This may be accomplished either by a separation unit,e.g., a loose film or by another solid component. Preferably theincompatible components are separated from one another by a thirdcomponent which is itself compatible with each of the two othercomponents.

Compatible here is defined as not causing any mutual changes in theirchemical and/or physical properties whereas incompatible or notcompatible is defined conversely. This is understood to mean that thecontainer is also exposed to extreme ambient conditions such as thoseprevailing during sterilization, for example, over a long storage time.

If two layers of incompatible solids are kept a distance apart by meansof another solid, i.e., a third solid, then the latter may be in theform of small polymer beads, for example, which are themselves insolublein water while the other solids are water-soluble. However, it ispreferable for the third solid to be another component for producing adialysate which then is especially preferably in the form of granules,powders or crystals and is also water-soluble.

Examples of components that are used for preparing the dialysate includeelectrolytes, acids, sodium chloride, sodium bicarbonate and glucose. Ofthe substances, sodium bicarbonate and glucose, for example, are notmutually compatible. Therefore, according to this invention, a layer ofsodium chloride is placed between the layer of sodium bicarbonate andthe layer of glucose.

Any type of solid cartridge or flexible bag is conceivable as thecontainer; it should be made of a material that is also compatible withits ingredients. In the field of medical technology, in the past mainlysolid cartridges made of polycarbonate or flexible bags made ofpolyvinylpyrrolidone have been provided for this purpose. However, thesehave been replaced to an increasing extent by polyolefins, especiallypolypropylene and polyethylene, in combination with synthetic rubbers.Special coatings which additionally provide a gas barrier or a watervapor barrier and offer special compatibilities or similar advantagesare described in numerous variations in the state of the art.

The container should have at least one inlet to be able to fill it withthe components. According to this invention, this inlet may also be usedas an outlet at the same time. However, it is also conceivable for theinlets and outlets to be provided separately and/or for multiple inletsand/or outlets to be provided. These containers may also haveconnections, such as injection ports and ventilation and aerationdevices or the like.

According to this invention, the solids are added to the container inlayers. In order for the layers not to slip during storage, it isadvantageous for the layers to be secured in place. It is conceivablehere for a covering plate to be pressed onto the layers of solids andfor such a plate to be lockable. However it is especially advantageousfor unneeded gases or liquids to be removed from the container, e.g., bysuction.

For this reason the preferred embodiment of this invention is a flexiblebag in which a vacuum is created with the help of a pump after addingthe solids layer by layer and which is then sealed airtight. It shouldbe noted here that a space that is completely empty of air can never beformed, which is why the correct description refers to an interior spaceof the bag which contains the smallest possible amount of gas or fluid.Likewise, the embodiment as a flexible bag is not absolutely necessarybut it is especially helpful if the solids contained in the bag are tobe secured in place with the help of a “vacuum pack.”

Securing the solids at their location inside the bag serves to preventmixing of the solids so that incompatible solids cannot come in contactwith each other. Although this invention is not limited to the use ofsolids for producing a dialysate, the preferred embodiment isnevertheless a flexible container which is filled with preferably allthe substances required to prepare a dialysate, but at least is filledwith solids that form a partial concentrate.

One conventional partial concentrate is prepared by using threesubstances, namely bicarbonate, sodium chloride and glucose. Glucose issubject to degradation when it comes in contact with an incompatiblesubstance that has a basic pH, i.e., bicarbonate in this case. This iseven more the case during hot steam sterilization. When two incompatiblesubstances such as sodium bicarbonate and glucose as in this case areused for the partial concentrate, the especially preferred embodiment isa flexible bag having three layers of solids consisting of glucose,sodium chloride and sodium bicarbonate, with sodium chloride forming themiddle layer and the layers being secured in place by suction removal ofthe air in the interior of the bag.

Such a filled bag is used for supplying the concentrate used to preparethe dialysate. It is especially advantageous if the amount present inthe bag is just sufficient to prepare exactly the amount of dialysatenecessary and sufficient for one dialysis.

1. A combination container and composition for preparing a dialysatesolution suitable for use in the treatment of kidney insufficiency,which comprises a container having at least one inlet or outlet, andthree solids, each solid being in a powder, granular or crystalline formand being water-soluble, at least two of said solids being incompatiblewith one another and separated from one another by a layer of said thirdsolid which is compatible with said at least two incompatible solids,each of solids being a component suitable for a dialysate solution usedin the treatment of kidney insufficiency.
 2. The combination containerand composition according to claim 1, wherein the third solid is sodiumchloride.
 3. A combination container and composition for producing adialysate solution suitable for use in the treatment of kidneyinsufficiency comprising: a container having at least one inlet and oneoutlet; a first solid and a second solid arranged in layers within saidcontainer; each solid being in a powdered, granular or crystalline form,being water-soluble, and being a component suitable for a dialysatesolution used in the treatment of kidney insufficiency; and when thefirst and second solids are incompatible with each other, said apparatusfurther including a third solid compatible with the first and secondincompatible solids, said third solid also being in a powdered, granularor crystalline form, being water-soluble, and being a component suitablefor a dialysate solution used in the treatment of kidney insufficiency,and disposed as a layer between the two incompatible solids.
 4. Thecombination container and composition of claim 3 wherein said at leasttwo solids are selected from the group consisting of electrolytes,acids, sodium chloride, sodium bicarbonate and glucose.
 5. Thecombination container and composition of claim 3, wherein the thirdsolid comprises sodium chloride.
 6. The combination container andcomposition of claim 5, wherein the container includes a vacuum seal. 7.The combination container and composition of claim 5, wherein thecontainer is flexible.
 8. The combination container and composition ofclaim 5, wherein the container is a flexible bag formed of a polymer. 9.A combination container and composition for producing a dialysatesolution suitable for use in the treatment of kidney insufficiencycomprising: a container having at least one inlet and one outlet; afirst solid and a second solid arranged in layers within said container;each solid being in a powdered, granular or crystalline form, beingwater-soluble, and being a component suitable for a dialysate solutionused in the treatment of kidney insufficiency; said container includes avacuum seal; and when the first and second solids are incompatible witheach other, said apparatus further including a third solid compatiblewith the first and second incompatible solids, said third solid alsobeing in a powdered, granular or crystalline form, being water-soluble,and being a component suitable for a dialysate solution used in thetreatment of kidney insufficiency, and disposed as a layer between thetwo incompatible solids.
 10. A combination container and composition forproducing a dialysate solution suitable for use in the treatment ofkidney insufficiency comprising: a flexible bag made of a polymerforming a container having at least one inlet and one outlet; at least afirst solid and a second solid, each solid being in a powdered, granularor crystalline form and being a component suitable for a dialysatesolution used in the treatment of kidney insufficiency, arranged inlayers within said container, said solids being water-soluble andselected from the group consisting of electrolytes, acids, sodiumchloride, sodium bicarbonate and glucose; when said first and secondsolids are incompatible with each other, said apparatus furtherincluding sodium chloride in a powdered, granular or crystalline formdisposed as a layer in between at least two incompatible solids; andsaid container further being vacuum sealed.